BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHTECH

    MDR report key: 532383 · Received March 4, 2004

    Report

    Report Number
    2246980-2004-00001
    Event Type
    Other
    Date Received
    March 4, 2004
    Date of Event
    November 6, 2003
    Report Date
    February 26, 2004
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF MANOMETER DURING EQUIPMENT CHECK PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHTECH RESUSCITATOR BTM VENTLAB CORP. UNK 3289-19

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY